This document is a comprehensive report resulting from an April 2017 workshop organized by leading scientific and academic organizations (FASEB, AAMC, COGR, with assistance from NABR) to address the regulatory burdens associated with animal research. Recognizing the critical role animal research plays in advancing science and healthcare, the report identifies numerous inefficient, conflicting, or outdated regulations that, rather than improving animal welfare, primarily create excessive administrative workload for researchers, institutions, and oversight committees (IACUCs). The report provides detailed, actionable recommendations—directed at federal agencies such as NIH and USDA, as well as Congress and the Executive Office of the President—with the goal of streamlining regulatory processes while maintaining high standards of animal welfare.
Among the major recommendations are the consolidation of federal oversight under a single office to harmonize regulations, the establishment of advisory groups of experienced animal researchers to assist in reviewing and updating regulations and guidance, and the adoption of risk-based oversight and review mechanisms akin to those used for human subject research. It also advocates for limiting mandatory facility inspections to an annual basis, aligning protocol review cycles between USDA and NIH, reducing redundant or ineffective reporting and literature search requirements, and clarifying the nonbinding nature of guidance documents. Further, the report requests Congressional amendments to key statutes to reduce administrative redundancies and enable more flexible, science-driven oversight. The document emphasizes that reducing regulatory burden will free up valuable resources, improve research efficiency, and better support both animal welfare and scientific progress, concluding with a call for prompt implementation of these reforms in light of the statutory mandate from the 21st Century Cures Act.
